MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE WITH BD BLUNT PLASTIC CANNULA; PISTON SYRINGE

Catalog Number	303346
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: initial reporter state: the initial reporter's state was determined to be oh based on the area code portion of the provided phone # a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd 3ml syringe with bd blunt plastic cannula experienced foreign matter contamination.The following information was provided by the initial reporter: stated part of the syringe / puncture pieces fell into the vial.
Event or Problem Description
It was reported that the bd 3ml syringe with bd blunt plastic cannula experienced foreign matter contamination.The following information was provided by the initial reporter: stated part of the syringe / puncture pieces fell into the vial.
Additional Manufacturer Narrative
H6: investigation summary: a device history review was conducted for batch number 2168854.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Please note that bd syringes with blunt plastic cannula are specifically designed for use with preslit injection sites.They are not compatible with other injection sites.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.H3 other text : see h.10.

• Brand Name: BD 3ML SYRINGE WITH BD BLUNT PLASTIC CANNULA
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15460439
• Report Number: 1213809-2022-00611
• Device Sequence Number: 17260248
• Product Code: FMF
• UDI-Device Identifier: 00382903033461
• UDI-Public: 00382903033461
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 303346
• Device Lot Number: 2168854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/21/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown